Clinical Trials for Brain Tumor

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adult patients with HER2-positive metastatic breast, lung, esophagogastric, or colorectal cancer with brain metastases requiring surgical resection (including those with prior or no prior tucatinib exposure) receive a 4-day pre-operative course of tucatinib, a selective HER2 tyrosine kinase inhibitor with CNS activity. Post-operative therapy is not dictated by the study.

ClinicalTrials.gov ID: NCT05892068

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and brain metastases whose tumors have abnormally active HER2 signaling (per CELsignia test), including both ER-positive and triple-negative subtypes, and treats them with the investigational HER2 pathway inhibitor neratinib plus capecitabine. Eligible patients must have appropriate prior treatment and be able to undergo biopsy and systemic therapy.

ClinicalTrials.gov ID: NCT04965064

Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with HER2-positive breast cancer and newly diagnosed brain metastases (1-10 lesions, each ≤3 cm) receive stereotactic radiosurgery combined with tucatinib (a selective HER2-directed tyrosine kinase inhibitor), trastuzumab, and capecitabine. Patients with leptomeningeal disease or significant cardiac history are excluded.

ClinicalTrials.gov ID: NCT05553522

Phase IIa Study Assessing QBS72S For Treating Brain Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with relapsed, metastatic CNS disease (either brain metastases or leptomeningeal disease); Cohorts 1 and 2 include breast cancer patients after prior chemotherapy, while Cohort 3 includes patients with leptomeningeal disease from any solid tumor. All participants receive QBS72S, a LAT1-targeted chemotherapeutic agent designed to selectively kill tumor cells with high LAT1 expression, given as monthly IV infusions until progression.

ClinicalTrials.gov ID: NCT05305365

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with biopsy-proven estrogen receptor (ER)-positive breast cancer and new or recurrent brain metastases who are candidates for planned radiation therapy, using investigational brain imaging with 18F-FES PET/CT (a radiotracer targeting ER expression) in addition to standard imaging to potentially enhance radiotherapy planning and response assessment.

ClinicalTrials.gov ID: NCT06072807

Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Relapsed/refractory primary CNS tumors in patients aged 6–25 (e.g., ependymoma, medulloblastoma, glioblastoma) with measurable disease and adequate organ function; key exclusions include active autoimmune disease requiring systemic therapy, significant cardiovascular/bleeding risks, warfarin/strong CYP3A inhibitors, and uncontrolled infection. Single-arm regimen of oral ibrutinib (BTK inhibitor) plus indoximod (IDO/TDO pathway modulator restoring T-cell function) with metronomic cyclophosphamide and etoposide in 28+ day cycles.

ClinicalTrials.gov ID: NCT05106296

Pilot Study of Sonodynamic Therapy With 5-ALA for the Treatment of Recurrent Glioblastoma Using Neuronavigation-Guided Low-Intensity Focused Ultrasound

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults (KPS 70–100) with measurable, surgically accessible recurrent glioblastoma scheduled for repeat craniotomy receive a single session of sonodynamic therapy using oral 5-ALA (prodrug metabolized to PpIX that accumulates in glioma cells) activated by neuronavigation-guided low-intensity focused ultrasound to a portion of the enhancing lesion 1–3 weeks before resection. Designed to assess safety/feasibility and preliminarily evaluate tumor devitalization, with key exclusions including porphyria/5-ALA hypersensitivity, recent chemo/radiation, anticoagulation that can’t be held, significant cardiopulmonary disease, or anatomy outside the NaviFUS treatment envelope.

ClinicalTrials.gov ID: NCT06039709

A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with IDH-wildtype glioblastoma at first recurrence undergoing planned resection and eligible for ≥50% resection are randomized post-op to an implanted SonoCloud-9 ultrasound device to transiently open the blood–brain barrier with each cycle of IV carboplatin versus standard single-agent lomustine or temozolomide. SonoCloud-9 is an investigational transcranial ultrasound system intended to enhance intratumoral carboplatin delivery to peritumoral regions.

ClinicalTrials.gov ID: NCT05902169

Genomically-Guided Treatment Trial in Brain Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with measurable parenchymal brain metastases from solid tumors and matched actionable alterations (CDK pathway, PI3K pathway, NTRK/ROS1 fusions, or KRAS G12C) receive genomically assigned, CNS-penetrant targeted therapy: abemaciclib (CDK4/6 inhibitor), paxalisib (PI3K/mTOR inhibitor), entrectinib (TRK/ROS1/ALK inhibitor), or adagrasib (KRAS G12C inhibitor). Prior SRS/WBRT/systemic therapy allowed; primary endpoint is intracranial response by BM-RANO.

ClinicalTrials.gov ID: NCT03994796

Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with progressive WHO grade 4 gliomas undergoing planned resection and eligible for postoperative chemotherapy receive sitagliptin (DPP-4 inhibitor targeting MDSC trafficking/function) given preoperatively in most patients and then continued with standard chemotherapy postoperatively. Aims to increase intratumoral CD8+ T-cell infiltration and assess PFS/OS and safety; excludes patients with prior gliptin use or uncontrolled diabetes requiring insulin/sulfonylureas.

ClinicalTrials.gov ID: NCT07003542